Comparison of IV PCA and Wound Infusion After Repair of Pectus Excavatum

NCT01908491 | Completed Phase 4

• 1 other identifier: pectus-pain study
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative pain management is a major problem after repair of pectus excavatum.Various methods of pain management have been introduced. However, the effects of continuous wound infusion of local anesthetics through ON-Q catheters were not well evaluated in pectus surgery. Therefore, we conducted prospective randomized controlled study to compare the effects of IV PCA and continuous wound infusion after repair of pectus excavatum.

Conditions

Pain; Side Effects

Keywords

patient controlled analgesia; wound catheter infusion; postoperative pain control; pectus excavatum; pain score

Outcome Measures

Primary Outcomes (1)

• Changes of pain score

  Pain score was measured by the Wong-Baker FACES pain scale at 1, 2, 6, 24, 48 hours after surgery. Pain scale consists of 6 faces with word descriptors and numbers from 0 to 10. The child look at the faces, the nurse or parent uses the words to describe the expression, and the child is asked to point to the face that describes how he/she feels. The number is used to record a pain score. This simple and quick scale can be easily reproduced for use at the bed-side with children as young as 3 years of age.

  during 48 hours after surgery

Secondary Outcomes (1)

• Incidence of side effects

  during 48 hours after surgery

Study Arms (2)

IV PCA

ACTIVE COMPARATOR

hydromorphone with ketorolac

Device: IV PCA

Continuous wound infusion

EXPERIMENTAL

ON-Q Painbuster with ropivacaine

Device: Continuous wound infusion

Interventions

IV PCA DEVICE

On arrival in the postanesthetic care unit, a patient-controlled analgesia (IV PCA) was connected to the iv catheter. The PCA regimen consisted of hydromorphone (2 mcg/kg/hr) and ketorolac (0.02 mg/kg/hr) with normal saline (total volume 100ml). PCA was programmed to deliver 1 ml/hr as background infusion and 1 ml per demand with a 10 min lockout during 48 hr period.

IV PCA

Continuous wound infusion DEVICE

Patients underwent insertion of wound catheters by the surgeon just before the closure of incision site. The wound catheters, consisting of double branch and connected to elastomeric pump filled with ropivacaine (0.15\~0.25%) and administered at a constant flow rate of 2 ml/hr in each branch of the catheter for 48 hr.

Continuous wound infusion

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patients undergoing the repair of pectus excavatum

You may not qualify if:

• allergy to opioid or local anesthetics
• reoperation

Sponsors & Collaborators

• The Catholic University of Korea: lead

Study Sites (1)

Seoul St. Mary's Hospital, the Catholic University of Korea

Seoul, 137-040, South Korea

Location

MeSH Terms

Conditions

Pain; Funnel Chest

Interventions

Analgesia, Patient-Controlled

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia

Study Officials

• Jeong Eun Kim, MD, PhD

  Seoul St. Mary's Hospital, the Catholic University of Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: July 19, 2013
• First Posted: July 25, 2013
• Study Start: October 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: November 14, 2013

Record last verified: 2013-11

Locations

KR (1)